P1, N=41, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting

P1, N=90, Not yet recruiting, Xencor, Inc.

P1, N=138, Recruiting, Aktis Oncology, Inc.

In pancreatic cancer, neuroblastoma, and glioblastoma xenograft models, CAR T cells incorporating the lead human binder Y111 are well tolerated and demonstrate superior antitumor activity compared with 376.96- and MGA271-based CARs. Y111 CAR treatment induces complete responses, tumor rejection, and significant survival benefits, identifying Y111 as a promising fully human B7-H3 CAR for solid tumors.

P1, N=175, Recruiting, Masonic Cancer Center, University of Minnesota

P1, N=41, Not yet recruiting, Shanghai Henlius Biotech

Toxicological evaluations in non-human primates reveals a favorable safety profile, with no EGFR-related adverse effects observed at doses up to 120 mg/kg over 4 weeks. Supported by these preclinical findings, IBI334 has advanced to a phase 1 clinical trial (NCT05774873) for advanced/metastatic solid tumors.

This study presents an injectable pH/ROS-dual-responsive hydrogel co-loaded with enoblituzumab (B7-H3 blocker) and Cl-amidine (NETs suppressor)...The hydrogel exhibits excellent biocompatibility without systemic toxicity. This TME-responsive combination strategy offers a promising approach to enhance immunotherapy efficacy and overcome immune resistance in OSCC.

P2, N=62, Active, not recruiting, Pediatric Brain Tumor Consortium | Trial completion date: Oct 2030 --> Sep 2027 | Trial primary completion date: Oct 2029 --> Mar 2026

In pancreatic cancer, neuroblastoma, and glioblastoma xenograft models, CAR T cells incorporating the lead human binder Y111 were well tolerated and demonstrated superior antitumor activity compared with 376.96- and MGA271-based CARs. Y111 CAR treatment induced complete responses, tumor rejection, and significant survival benefits, identifying Y111 as a promising fully human B7-H3 CAR for solid tumors.

P1/2, N=61, Recruiting, Radiopharm Theranostics, Ltd | Not yet recruiting --> Recruiting | Initiation date: Nov 2025 --> Feb 2026

In our experience, MYCN amplification and concomitant extra-CNS metastases at CNS relapse significantly decrease OS. Multimodal treatment, including 131I-omburtamab radioimmunotherapy, significantly improves survival outcomes.